Spinal implant system and method

ABSTRACT

A surgical instrument comprises a first member including a drive engageable with a first mating surface of a bone fastener. A second member is rotatable relative to the first member and includes an element engageable with a second mating surface of the bone fastener. An actuator is connected with the second member and includes visual indicia of engagement of the element with the second mating surface. Systems, spinal implants and methods are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/661,962, filed on Jul. 27, 2017, which is hereby expresslyincorporated herein by reference, in its entirety.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to aspinal implant system and a method for treating a spine.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor and fracture may resultfrom factors including trauma, disease and degenerative conditionscaused by injury and aging. Spinal disorders typically result insymptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. As part of these surgical treatments, spinalconstructs such as vertebral rods are often used to provide stability toa treated region. Rods redirect stresses away from a damaged ordefective region while healing takes place to restore proper alignmentand generally support vertebral members. During surgical treatment, oneor more rods and bone fasteners can be delivered to a surgical site. Therods may be attached via the fasteners to the exterior of two or morevertebral members. Surgical treatment may employ surgical instrumentsand implants that are manipulated for engagement with vertebrae toposition and align one or more vertebrae. This disclosure describes animprovement over these prior technologies.

SUMMARY

In one embodiment, a surgical instrument is provided. The surgicalinstrument comprises a first member including a drive engageable with afirst mating surface of a bone fastener. A second member is rotatablerelative to the first member and includes an element engageable with asecond mating surface of the bone fastener. An actuator is connectedwith the second member and includes visual indicia of engagement of theelement with the second mating surface. In some embodiments, systems,spinal implants and methods are disclosed.

In one embodiment, the surgical instrument includes an outer tubularsleeve extending between a proximal end and a distal end. The distal endincluding a drive engageable with a drive socket of a bone fastenershaft. An inner shaft is rotatable relative to the sleeve and includes ascrew connectable with an inner threaded surface of a bone fastenerreceiver. A rotatable actuator is connected with the inner shaft andincludes visual indicia of a non-locking configuration and a lockingconfiguration with the inner threaded surface.

In one embodiment, a spinal implant system is provided. The spinalimplant system comprises a surgical instrument including an outertubular sleeve extending between a proximal end and a distal endincluding a drive engageable with a bone fastener shaft. An inner shaftis rotatable relative to the sleeve and includes a screw connectablewith a threaded surface of a bone fastener receiver. The surgicalinstrument further includes a rotatable actuator connected with theinner shaft and includes visual indicia of a non-locking configurationand a locking configuration with the threaded surface. A guide memberincludes an inner surface that defines a cavity configured for disposalof the sleeve and an image guide is oriented relative to a sensor tocommunicate a signal representative of a position of the guide member.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 3 is a break away cross section view of components of oneembodiment of a surgical system in accordance with the principles of thepresent disclosure;

FIG. 4 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 5 is a break away cross section view of components of oneembodiment of a surgical system in accordance with the principles of thepresent disclosure;

FIG. 6 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure with parts separated;

FIG. 7 is a cross section view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 8 is a break away view of the components shown in FIG. 7 ;

FIG. 9 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 10 is a perspective view of components one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 11 is a perspective view of components one embodiment of a surgicalsystem in accordance with the principles of the present disclosure; and

FIG. 12 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a spinal implant system and a method for treating a spine. In someembodiments, the systems and methods of the present disclosure comprisemedical devices including surgical instruments and implants that areemployed with a surgical treatment, as described herein, for example,with a cervical, thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system comprises a surgicalinstrument that comprises a screw driver that can be employed with bonefasteners and one or more implant supports, such as, for example, anextender, for treating a spine. In some embodiments, the presentsurgical system includes a surgical instrument that can easily connectand disconnect from a bone fastener. In some embodiments, an extendercan be connected in alignment with the surgical instrument to facilitatemanipulation. In some embodiments, the present surgical system includesa surgical instrument that can be employed with an end effector of arobotic arm to facilitate implant with the robotic arm. In someembodiments, the surgical instrument is guided through the end effectorfor a guide-wireless screw insertion. In some embodiments, the surgicalinstrument comprises a robot screw driver employed with robotic and/ornavigation guidance, which may include an image guide.

In some embodiments, the present surgical system comprises a surgicalinstrument that comprises a screw driver with a disengagement feature.In some embodiments, the present surgical system comprises a surgicalinstrument that comprises a screw driver with a disengagement featurefor robotic guidance. In some embodiments, the screw driver includes aknob that serves as a visual indicator of whether or not the driver isfully disengaged from an implant. In some embodiments, the screw driveris employed with robotic guidance and has an inner shaft assembly thatprovides indicia of the driver being fully unthreaded from an implant.In some embodiments, the screw driver provides visual indicia that thescrew driver is unthreaded from the implant in a minimally invasivesurgical procedure. For example, the screw driver provides visualindicia whether the screw driver is or is not engaged.

In some embodiments, the present surgical system comprises a surgicalinstrument that comprises a driver having a torx tip configured forengagement with a bone fastener. In some embodiments, the driverincludes a thumb wheel configured to actuate translation of thethumbwheel between a first, engaged positon and a second disengagedposition. In some embodiments, in the engaged position, the torx tip isengaged with the bone fastener. In some embodiments, the thumb wheel isconfigured to indicate the position of the torx tip relative to the bonefastener. In some embodiments, the thumb wheel is configured to bepushed and rotated to engage the torx tip with the bone fastener. Insome embodiments, the thumb wheel is disposed in the second positon andthe driver is disengaged from the bone fastener. In some embodiments,the driver is configured for use with an open tulip bone fastener. Insome embodiments, the driver includes an inner shaft configured fortranslation relative to an outer sleeve. In some embodiment, the innershaft includes a threaded end configured for engagement with the bonefastener. In some embodiments, the position of the thumb wheel providesa visual indicator of engagement and disengagement of the inner shaftwith the bone fastener. In some embodiments, the visual indicatorfacilitates removal of the driver in minimally invasive surgicalprocedures.

In some embodiments, the present surgical system comprises a method ofassembly for a surgical instrument that comprises a driver. In someembodiments, the method includes the step of inserting a thumb wheel anda screw with an outer sleeve. In some embodiments, the method includesthe step of translating an inner shaft into the outer sleeve and throughthe thumb wheel and the screw. In some embodiments, the method includesthe step of engaging a pin with the thumb wheel and the inner shaft tofix the thumb wheel with the inner shaft. In some embodiments, themethod includes the step of engaging a pin with the screw and the innershaft to fix the screw with the inner shaft. In some embodiments, thepins are connected by laser welding. In some embodiments, the methodincludes the step connecting a quick connect shaft with the outersleeve. In some embodiments, the quick connect shaft is welded to theouter sleeve.

In some embodiments, the present surgical system includes a screw driverhaving an outer shaft and a drive tip that engages a bone fastener. Insome embodiments, the outer shaft and the drive tip are of one piececonstruction. In some embodiments, the one piece construction allowstolerances to be controlled tightly for improved accuracy of trajectoryduring implant insertion. In some embodiments, the drive tip includes aTorx configuration. In some embodiments, the present surgical systemincludes a screw driver having an internal retention mechanism. In someembodiments, the retention mechanism is fixed with a receiver of a bonefastener to resist and/or prevent disengagement of the retentionmechanism from the receiver, for example, due to connection or frictionwith the end effector or tissue.

In some embodiments, the present surgical system includes a screw driverfor use with robotic surgery. In some embodiments, the screw driver canbe employed with fixed-axis screws (FAS), uni-axial screws (UAS),sagittal adjusting screws (SAS), transverse sagittal adjusting screws(TSAS) and multi-axial screws (MAS) screws, and allows the screws to bedriven through a robotic end effector. In some embodiments, the screwdriver includes a one piece outer sleeve having a tip. In someembodiments, the screw driver includes an internal retaining device thatprevents accidental disengagement and/or unthreading.

In some embodiments, the present surgical system includes a screw driverincluding an outer shaft or sleeve having an outside diameter that isslightly larger than a screw spin diameter of a bone screw. Thisconfiguration allows the bone screw and the screw driver to pass throughan end effector. In some embodiments, the screw driver includes a thumbwheel that is connected to a retention screw that threads into the bonescrew.

In some embodiments, the present surgical system includes a screw driverthat includes a quick connect shaft, an inner shaft, a thumb wheel, anouter driver shaft and a retention screw. In some embodiments, the screwdriver includes cleaning slots for flushing and/or cleaning. In someembodiments, the surgical system is employed with a method for treatingspinal trauma and/or deformity disorders with a minimally invasivesurgical technique.

In some embodiments, the surgical system of the present disclosure maybe employed to treat spinal disorders such as, for example, degenerativedisc disease, disc herniation, osteoporosis, spondylolisthesis,stenosis, scoliosis and other curvature abnormalities, kyphosis, tumorand fractures. In some embodiments, the surgical system of the presentdisclosure may be employed with other osteal and bone relatedapplications, including those associated with diagnostics andtherapeutics. In some embodiments, the disclosed surgical system may bealternatively employed in a surgical treatment with a patient in a proneor supine position, and/or employ various surgical approaches to thespine, including anterior, posterior, posterior mid-line, directlateral, postero-lateral, and/or antero-lateral approaches, and in otherbody regions. The surgical system of the present disclosure may also bealternatively employed with procedures for treating the lumbar,cervical, thoracic, sacral and pelvic regions of a spinal column. Thesurgical system of the present disclosure may also be used on animals,bone models and other non-living substrates, such as, for example, intraining, testing and demonstration.

The surgical system of the present disclosure may be understood morereadily by reference to the following detailed description of theembodiments taken in connection with the accompanying drawing figures,which form a part of this disclosure. It is to be understood that thisapplication is not limited to the specific devices, methods, conditionsor parameters described and/or shown herein, and that the terminologyused herein is for the purpose of describing particular embodiments byway of example only and is not intended to be limiting. In someembodiments, as used in the specification and including the appendedclaims, the singular forms “a,” “an,” and “the” include the plural, andreference to a particular numerical value includes at least thatparticular value, unless the context clearly dictates otherwise. Rangesmay be expressed herein as from “about” or “approximately” oneparticular value and/or to “about” or “approximately” another particularvalue. When such a range is expressed, another embodiment includes fromthe one particular value and/or to the other particular value.Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. It is also understood that all spatialreferences, such as, for example, horizontal, vertical, top, upper,lower, bottom, left and right, are for illustrative purposes only andcan be varied within the scope of the disclosure. For example, thereferences “upper” and “lower” are relative and used only in the contextto the other, and are not necessarily “superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. In some embodiments, as used inthe specification and including the appended claims, the term “tissue”includes soft tissue, ligaments, tendons, cartilage and/or bone unlessspecifically referred to otherwise.

The following discussion includes a description of a surgical systemincluding a surgical instrument, related components and methods ofemploying the surgical system in accordance with the principles of thepresent disclosure. Alternate embodiments are also disclosed. Referenceis made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningto FIGS. 1-12 , there are illustrated components of a surgical system,such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, aluminum, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL®), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyimide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 is employed, for example, with a fully opensurgical procedure, a minimally invasive procedure includingpercutaneous techniques, and mini-open surgical techniques to deliverand introduce instrumentation and/or a spinal implant, such as, forexample, a bone fastener, at a surgical site of a patient, whichincludes, for example, a spine. In some embodiments, the spinal implantcan include one or more components of one or more spinal constructs,such as, for example, interbody devices, interbody cages, bonefasteners, spinal rods, tethers, connectors, plates and/or bone graft,and can be employed with various surgical procedures including surgicaltreatment of a cervical, thoracic, lumbar and/or sacral region of aspine.

Spinal implant system 10 includes a surgical instrument, such as, forexample, a driver 12. Driver 12 can be employed with an end effector 200(FIG. 10 ) of a robotic arm R (FIG. 12 ) to facilitate implant withrobotic arm R. Driver 12 is guided through end effector 200 forguide-wireless insertion of a spinal implant, such as, for example, abone fastener 100, as described herein.

Driver 12 includes a member, such as, for example, an outer tubularsleeve 14. Outer sleeve 14 extends between a proximal end 18 and adistal end 20. Outer sleeve 14 defines a longitudinal axis a. In someembodiments, outer sleeve 14 may have various configurations including,for example, round, oval, polygonal, irregular, consistent, variable,uniform and non-uniform. Outer sleeve 14 includes a diameter D1. In someembodiments, diameter D1 is slightly larger than a screw spin diameterD2 of bone fastener 100. This configuration allows bone fastener 100 anddriver 12 to pass through end effector 200 of the robotic arm, asdescribed herein.

Outer sleeve 14 includes a surface 50 that defines a channel 52. Channel52 is configured for disposal of a member, such as, for example, aninner shaft 56 and an engagement element, such as, for example, a screw64, as described herein. Outer sleeve 14 includes a collar body 16having a surface 80. Surface 80 defines a cavity 82. Body 16 includesbifurcated arms 92 disposed about cavity 82 to facilitate disposal andaccess to an actuator, such as, for example, a thumb wheel 84 therein.Body 16 includes opening 94 disposed at end 18. Opening 94 is incommunication with cavity 82 and in alignment with channel 52 tofacilitate insertion of inner shaft 56 into end 18, through wheel 84 andinto channel 52 for assembly, as described herein. Wheel 84 isconfigured to actuate rotation of inner shaft 56 and screw 64, asdescribed herein. Wheel 84 includes a surface 86 that defines a cavity88. Cavity 88 is configured for disposal of a correspondingly shapedportion of inner shaft 56, as shown in FIGS. 6-8 .

Inner shaft 56 extends between an end 60 and an end 62. End 60 isengageable with wheel 84 for rotation of inner shaft 56 and screw 64, asdescribed herein. In some embodiments, inner shaft 56 is fixed withwheel 84 by a pin 204, as shown in FIG. 6 . Pin 204 is configured to fixwheel 84 relative to inner shaft 56 to resist and/or prevent rotation ofwheel 84 relative to inner shaft 56 to facilitate simultaneous rotationof wheel 84, inner shaft 56 and screw 64, as described herein. In someembodiments, surface 86 engages end 60 in an interference fit. In someembodiments, cavity 88 includes various configurations, such as, forexample, hexalobe, cruciform, phillips, square, hexagonal, polygonal,star cross sectional configuration for a mating engagement withcorrespondingly shaped portion of inner shaft 56. In some embodiments,wheel 84 includes a surface 90 configured to facilitate gripping ofwheel 84, such as, for example a knurled surface.

Screw 64 includes an inner surface 66. Surface 66 defines a cavity 68configured for disposal of a correspondingly shaped portion of end 62 ofinner shaft 56. In some embodiments, inner shaft 56 is fixed with screw64 by a pin 206, as shown in FIG. 6 . Pin 206 is configured to fix screw64 relative to inner shaft 56 to resist and/or prevent rotation of screw64 relative to inner shaft 56 to facilitate simultaneous rotation ofwheel 84, inner shaft 56 and screw 64, as described herein. In someembodiments, surface 66 engages inner shaft 56 in an interference fit.In some embodiments, cavity 68 includes various configurations, such as,for example, hexalobe, cruciform, phillips, square, hexagonal,polygonal, star cross sectional configuration for a mating engagementwith a correspondingly shaped end 62. Screw 64 includes an outer surfacehaving a thread form 89. Thread form 89 is configured for engagementwith a mating surface, such as, for example, thread forms of arms 104,106 of bone fastener 100 to pull and or draw bone fastener 100 intoengagement with driver 12, as described herein.

Wheel 84 is translatable within cavity 82 causing simultaneous axialmovement of inner shaft 56 and screw 64 relative to outer sleeve 14. Insome embodiments, body 16 includes ends 201, 202. Ends 201, 202 define arange of axial translation of wheel 84 relative to outer sleeve 14.Wheel 84 is moveable relative to outer sleeve 14 between a proximalposition and a distal position. In the proximal position, wheel 84provides visual indicia of a non-locking configuration of screw 64relative to bone fastener 100, as shown in FIGS. 4 and 5 . In the distalposition, wheel 84 provides visual indicia of a locking configuration ofscrew 64 relative to bone fastener 100, as shown in FIGS. 2 and 3 .

Wheel 84 provides visual indicia displaying the locking and/ornon-locking configuration of screw 64 by a position of wheel 84 relativeto outer sleeve 14. For example, wheel 84 translates, in a directionshown by arrow A in FIG. 2 , such that a gap G1 is viewable. Gap G1 isdisposed between wheel 84 and end 202. Gap G1 is viewable to indicatethat screw 64 is disposed in the locking configuration relative to bonefastener 100. Wheel 84 translates, in a direction shown by arrow B inFIG. 4 , closing gap G1 such that a gap G2 is viewable. Gap G2 isdisposed between wheel 84 and end 201. Gap G2 is viewable to indicatethat screw 64 is disposed in the non-locking configuration relative tobone fastener 100. Translation of wheel 84 and the visual indiciaindicating the disengaged, non-locking configuration of screw 64relative to bone fastener 100 facilitates removal of driver 12 inminimally invasive surgical procedures.

In some embodiments, the indicia of a non-locking and/or a lockingconfiguration may include alternative visual indicia, tactile indicia,audible indicia, one or more components having markers foridentification under x-ray, fluoroscopy, CT or other imaging techniques,at least one light emitting diode, a wireless component, a wiredcomponent, a near field communication component and/or one or morecomponents that generate acoustic signals, magnetic signals,electromagnetic signals and/or radiologic signals. In some embodiments,the indicia includes a notch, slot, bead, detent, bump, print, label,score, color coding and/or cavity disposed on wheel 84. In someembodiments, the indicia may be attachable with or adhered to wheel 84.

Screw 64 is inserted laterally into channel 52. Wheel 84 is insertedlaterally into cavity 82. With wheel 84 and screw 64 provisionallyassembled with outer sleeve 14, inner shaft 56 is inserted from end 18,through opening 94, through cavity 88 and into channel 52 such that end62 engages and passes through screw 64. Screw 64 is disposed with innershaft 56 and wheel 84 is disposed with collar body 16, within channel52, for assembly of the components of driver 12. As shaft 70 is insertedand attached with end 18 to assemble and retain inner shaft 56, wheel84, and screw 64 within channel 52 in a relatively movable configurationwith outer sleeve 14, as described herein. In some embodiments, shaft 70is attached with end 18 such that inner shaft 56, wheel 84, screw 64simultaneously slide, translate, rotate and/or float within channel 52.Inner shaft 56 retains screw 64 and wheel 84 with sleeve 14. In someembodiments, shaft 70 is welded with outer sleeve 14. In someembodiments, shaft 70 is configured to facilitate connection of driver12 with a surgical instrument, such as, for example, an actuator/drill250, as shown in FIG. 11 . In some embodiments, shaft 70 includes quickconnect surfaces or keyed geometry, such as, for example, triangle, hex,square or hexalobe to facilitate connection with actuator 250.

End 20 of outer sleeve 14 includes a distal tip, such as, for example,drive 22, as shown in FIG. 4 . Drive 22 is integrally connected ormonolithically formed with outer sleeve 14. This configurationfacilitates control of tolerances to optimize accuracy of the connectionof outer sleeve 14 with bone fastener 100. Drive 22 is engageable with aspinal implant, such as, for example, bone fastener 100. For example,drive 22 fits with and is engageable with a mating surface, such as, forexample, a socket 110 of bone fastener 100. Rotation of outer sleeve 14simultaneously rotates drive 22 to drive, torque, insert or otherwiseconnect bone fastener 100 with tissue, as described herein. In someembodiments, drive 22 includes a hexalobe geometry for a matingengagement with a correspondingly shaped socket 110. In someembodiments, drive 22 can alternatively include a cruciform, phillips,square, hexagonal, polygonal, star cross sectional configuration fordisposal of a correspondingly shaped socket 110.

Bone fastener 100 includes receiver 102. Receiver 102 extends along axisa when connected with outer sleeve 14. Receiver 102 includes a pair ofspaced apart arms 104, 106 that define an implant cavity configured fordisposal of a component of a spinal construct, such as, for example, aspinal rod (not shown). Receiver 102 includes socket 110 configured forengagement with drive 22, as described herein. Receiver 102 includes aninner surface having a thread form located adjacent arm 104 and a threadform located adjacent arm 106. The thread forms of arms 104, 106 areconfigured for engagement with thread form 89 to retain bone fastener100 with driver 12, as described herein. Bone fastener 100 includes athreaded shaft 116. Shaft 116 is configured to penetrate tissue, suchas, for example, bone.

In use, bone fastener 100 is connected with driver 12, as describedherein, and drive 22 is oriented for engagement with socket 110. Drive22 is engaged with socket 110 and screw 64 is disposed with inner shaft56 and assembled with outer sleeve 14 for axial translation relative toouter sleeve 14 and along inner shaft 56 between a non-lockingconfiguration, as shown in FIGS. 4 and 5 , and a locking configuration,as shown in FIGS. 2 and 3 with a spinal implant, such as, for example,bone fastener 100.

Wheel 84 is disposed in the proximal position and provides visualindicia, including gap G2, of the non-locking configuration of screw 64relative to bone fastener 100, as shown in FIG. 4 . Drive 22 is engagedwith socket 110 such that bone fastener 100 is connected with outersleeve 14, and thread form 89 is aligned with the thread forms of arms104, 106 for engagement therebetween to retain bone fastener 100 withdriver 12, as shown in FIG. 5 . Wheel 84 is manipulated for rotationsuch that inner shaft 56 rotates screw 64 relative to and independent ofouter sleeve 14. Thread form 89 engages the thread forms of arms 104,106 and screw 64 axially translates into receiver 102 and relative toinner shaft 56. The threaded engagement of screw 64 and receiver 102pulls and/or draws bone fastener 100 into the locking configuration withdriver 12 for releasable fixation therebetween, as shown in FIG. 3 .Wheel 84 is disposed in the distal position and provides visual indicia,including gap G1, of the locking configuration of screw 64 relative tobone fastener 100, as shown in FIG. 2 .

Drive 22 is connected with outer sleeve 14, as described herein, andouter sleeve 14 is rotated to drive, torque, insert or otherwise connectbone fastener 100 with adjacent tissue. Screw 64 remains releasablyfixed with receiver 102, independent of outer sleeve 14 rotation and/orengagement or friction with components of spinal implant system 10 asdescribed herein, to resist and/or prevent disengagement or unthreadingof screw 64 from receiver 102. In some embodiments, wheel 84 ismanipulated for rotation such that screw 64 rotates relative to outersleeve 14, and thread form 89 disengages the thread forms of arms 104,106. Screw 64 axially translates from receiver 102 to unthread driver 12from receiver 102 such that wheel 84 is disposed in the proximalposition and provides visual indicia, including gap G2, of thenon-locking configuration of screw 64 relative to bone fastener 100, asshown in FIG. 4 .

In some embodiments, driver 12 includes a navigation component 300, asshown in FIGS. 11 and 12 . Driver 12 is configured for disposal adjacenta surgical site such that navigation component 300 is oriented relativeto a sensor array 302 to facilitate communication between navigationcomponent 300 and sensor array 302 during a surgical procedure, asdescribed herein. Navigation component 300 is configured to generate asignal representative of a position of bone fastener 100 relative todriver 12 and/or tissue. In some embodiments, the image guide mayinclude human readable visual indicia, human readable tactile indicia,human readable audible indicia, one or more components having markersfor identification under x-ray, fluoroscopy, CT or other imagingtechniques, at least one light emitting diode, a wireless component, awired component, a near field communication component and/or one or morecomponents that generate acoustic signals, magnetic signals,electromagnetic signals and/or radiologic signals. In some embodiments,navigation component 300 is connected with shaft 70 or outer sleeve 14via an integral connection, friction fit, pressure fit, interlockingengagement, mating engagement, dovetail connection, clips, barbs, tonguein groove, threaded, magnetic, key/keyslot and/or drill chuck.

Navigation component 300 includes an emitter array 304. Emitter array304 is configured for generating a signal to sensor array 302 of asurgical navigation system 306, as shown in FIG. 12 and describedherein. In some embodiments, the signal generated by emitter array 304represents a position of bone fastener 100 relative to driver 12 andrelative to tissue, such as, for example, bone. In some embodiments, thesignal generated by emitter array 304 represents a three dimensionalposition of bone fastener 100 relative to tissue.

In some embodiments, sensor array 302 receives signals from emitterarray 304 to provide a three-dimensional spatial position and/or atrajectory of bone fastener 100 relative to driver 12 and/or tissue.Emitter array 304 communicates with a processor of computer 308 ofnavigation system 306 to generate data for display of an image onmonitor 310, as described herein. In some embodiments, sensor array 302receives signals from emitter array 304 to provide a visualrepresentation of a position of bone fastener 100 relative to driver 12and/or tissue. See, for example, similar surgical navigation componentsand their use as described in U.S. Pat. Nos. 6,021,343, 6,725,080,6,796,988, the entire contents of each of these references beingincorporated by reference herein.

Surgical navigation system 306 is configured for acquiring anddisplaying medical imaging, such as, for example, x-ray imagesappropriate for a given surgical procedure. In some embodiments,pre-acquired images of a patient are collected. In some embodiments,surgical navigation system 306 can include an O-arm® imaging device 310sold by Medtronic Navigation, Inc. having a place of business inLouisville, Colo., USA. Imaging device 310 may have a generally annulargantry housing that encloses an image capturing portion 312.

In some embodiments, navigation system 306 comprises an image capturingportion 314 that may include an x-ray source or emission portion and anx-ray receiving or image receiving portion located generally or aspractically possible 180 degrees from each other and mounted on a rotor(not shown) relative to a track of image capturing portion 314. Imagecapturing portion 314 can be operable to rotate 360 degrees during imageacquisition. Image capturing portion 314 may rotate around a centralpoint or axis, allowing image data of the patient to be acquired frommultiple directions or in multiple planes. Surgical navigation system306 can include those disclosed in U.S. Pat. Nos. 8,842,893, 7,188,998;7,108,421; 7,106,825; 7,001,045; and 6,940,941; the entire contents ofeach of these references being incorporated by reference herein.

In some embodiments, surgical navigation system 306 can include C-armfluoroscopic imaging systems, which can generate three-dimensional viewsof a patient. The position of image capturing portion 314 can beprecisely known relative to any other portion of an imaging device ofnavigation system 306. In some embodiments, a precise knowledge of theposition of image capturing portion 314 can be used in conjunction witha tracking system 316 to determine the position of image capturingportion 314 and the image data relative to the patient.

Tracking system 316 can include various portions that are associated orincluded with surgical navigation system 306. In some embodiments,tracking system 316 can also include a plurality of types of trackingsystems, such as, for example, an optical tracking system that includesan optical localizer, such as, for example, sensor array 302 and/or anEM tracking system that can include an EM localizer. Various trackingdevices can be tracked with tracking system 316 and the information canbe used by surgical navigation system 306 to allow for a display of aposition of an item, such as, for example, a patient tracking device, animaging device tracking device 318, and an instrument tracking device,such as, for example, emitter array 304, to allow selected portions tobe tracked relative to one another with the appropriate tracking system.

In some embodiments, the EM tracking system can include theSTEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation,Inc. having a place of business in Louisville, Colo. Exemplary trackingsystems are also disclosed in U.S. Pat. Nos. 8,057,407, 5,913,820,5,592,939, the entire contents of each of these references beingincorporated by reference herein.

Fluoroscopic images taken are transmitted a computer 314 where they maybe forwarded to computer 308. Image transfer may be performed over astandard video connection or a digital link including wired andwireless. Computer 308 provides the ability to display, via monitor 310,as well as save, digitally manipulate, or print a hard copy of thereceived images. In some embodiments, images may also be displayed tothe surgeon through a heads-up display.

In some embodiments, surgical navigation system 306 provides forreal-time tracking of the position of bone fastener 100 relative todriver 12 and/or tissue can be tracked. Sensor array 302 is located insuch a manner to provide a clear line of sight with emitter array 304,as described herein. In some embodiments, fiducial markers 330 ofemitter array 304 communicate with sensor array 302 via infraredtechnology. Sensor array 302 is coupled to computer 308, which may beprogrammed with software modules that analyze signals transmitted bysensor array 302 to determine the position of each object in a detectorspace.

Driver 12 is configured for use with a guide member, such as, forexample, an end effector 200 of a robotic arm R. End effector 200includes a surface 220 that defines a cavity, such as, for example, achannel 222. Channel 222 is configured for passage of bone fastener 100and disposal of driver 12. Robotic arm R includes position sensors (notshown), similar to those referenced herein, which measure, sample,capture and/or identify positional data points of end effector 200 inthree dimensional space for a guide-wireless insertion of bone fasteners100 with selected vertebral levels. In some embodiments, the positionsensors of robotic arm R are employed in connection with surgicalnavigation system 306 to measure, sample, capture and/or identifypositional data points of end effector 200 in connection with surgicaltreatment, as described herein. The position sensors are mounted withrobotic arm R and calibrated to measure positional data points of endeffector 200 in three dimensional space, which are communicated tocomputer 308.

In assembly, operation and use, spinal implant system 10, similar to thesystems and methods described herein, is employed with a surgicalprocedure, such as, for example, a treatment of an applicable conditionor injury of an affected section of a spinal column and adjacent areaswithin a body. In some embodiments, one or all of the components ofspinal implant system 10 can be delivered or utilized as a pre-assembleddevice or can be assembled in situ. Spinal implant system 10 may becompletely or partially revised, removed or replaced.

In use, to treat vertebrae (not shown), a medical practitioner obtainsaccess to a surgical site in any appropriate manner, such as throughincision and retraction of tissues. In some embodiments, spinal implantsystem 10 can be used in any existing surgical method or techniqueincluding open surgery, mini-open surgery, minimally invasive surgeryand percutaneous surgical implantation, whereby the vertebrae isaccessed through a mini-incision, or sleeve that provides a protectedpassageway to the area. Once access to the surgical site is obtained,the particular surgical procedure can be performed for treating thespine disorder.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway for implantation of components ofspinal implant system 10. A preparation instrument (not shown) can beemployed to prepare tissue surfaces of the vertebrae as well as foraspiration and irrigation of a surgical region.

Pilot holes (not shown) are made in selected levels of vertebrae forreceiving bone fasteners 100. Wheel 84 is disposed in the proximalposition and provides visual indicia, including gap G2, of thenon-locking configuration of screw 64 relative to bone fastener 100, asshown in FIG. 4 . Bone fastener 100 is connected with driver 12, asdescribed herein. Wheel 84 is rotated such that threaded engagement ofscrew 64 and receiver 102 pulls and/or draws bone fastener 100 into thelocking configuration with driver 12 for releasable fixationtherebetween, as shown in FIG. 3 . Wheel 84 is disposed in the distalposition and provides visual indicia, including gap G1, of the lockingconfiguration of screw 64 relative to bone fastener 100, as shown inFIG. 2 .

Driver 12, connected with bone fastener 100, is oriented for disposalwith end effector 200 of robotic arm R, as described herein. Theassembly of driver 12/bone fastener 100 is disposed with channel 220 forimplantation of one or more bone fasteners 100 with vertebrae employingrobotic arm R and/or surgical navigation system 306, as describedherein. Actuator 250 is connected with shaft 70 and drive 22 engagesbone fastener 100, as described herein, and outer sleeve 14 is rotatedto drive, torque, insert or otherwise connect bone fastener 100 withadjacent tissue. Screw 64 remains releasably fixed with receiver 102,independent of outer sleeve 14 rotation and/or engagement or frictionwith end effector 200 to resist and/or prevent disengagement orunthreading of screw 64 from receiver 102. In some embodiments, driver12 is manipulated to deliver one or more bone fasteners 100 to asurgical site including vertebrae.

Sensor array 302 receives signals from navigation component 300 toprovide a three-dimensional spatial position and/or a trajectory of theassembly of driver 12/bone fastener 100, which may be disposed with endeffector 200, relative to vertebrae and/or components of spinal implantsystem 10 for display on monitor 310. Wheel 84 is manipulated forrotation such that screw 64 rotates relative to outer sleeve 14, andthread form 89 disengages the thread forms of arms 104, 106. Screw 64axially translates from receiver 102 to unthread driver 12 from receiver102 such that wheel 84 is disposed in the proximal position and providesvisual indicia, including gap G2, of the non-locking configuration ofscrew 64 relative to bone fastener 100, as shown in FIG. 4 .

Upon completion of a procedure, as described herein, the surgicalinstruments, assemblies and non-implanted components of spinal implantsystem 10 are removed and the incision(s) are closed. One or more of thecomponents of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, spinal implant system 10 may include one or aplurality of spinal rods, plates, connectors and/or bone fasteners foruse with a single vertebral level or a plurality of vertebral levels.

In some embodiments, one or more bone fasteners, as described herein,may be engaged with tissue in various orientations, such as, forexample, series, parallel, offset, staggered and/or alternate vertebrallevels. In some embodiments, the bone fasteners may comprise multi-axialscrews, sagittal adjusting screws, pedicle screws, mono-axial screws,uni-planar screws, facet screws, fixed screws, tissue penetratingscrews, conventional screws, expanding screws, wedges, anchors, buttons,clips, snaps, friction fittings, compressive fittings, expanding rivets,staples, nails, adhesives, posts, fixation plates and/or posts.

In one embodiment, spinal implant system 10 includes an agent, which maybe disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the components and/orsurfaces of spinal implant system 10 with vertebrae. In someembodiments, the agent may include one or a plurality of therapeuticagents and/or pharmacological agents for release, including sustainedrelease, to treat, for example, pain, inflammation and degeneration.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A surgical instrument comprising: a first memberincluding a drive engageable with a first mating surface of a bonefastener; and a second member including a screw engageable with a secondmating surface of the bone fastener, the screw being fixed to a distalend of the second member by a pin, the screw having an outer threadsurface connectable with the second mating surface, the first memberdefining an inner cavity, the second member being rotatably disposedwithin the inner cavity.
 2. The surgical instrument recited in claim 1,wherein the screw has a maximum diameter, the maximum diameter of thescrew being greater than a maximum diameter of the drive.
 3. Thesurgical instrument recited in claim 1, wherein the first memberincludes a tubular wall extending along a longitudinal axis betweenopposite first and second end surfaces, the drive extending outwardlyfrom the second end surface such that the drive is coaxial with thelongitudinal axis.
 4. The surgical instrument recited in claim 3,wherein the second end surface extends perpendicular to the longitudinalaxis.
 5. The surgical instrument recited in claim 1, wherein the firstmember includes a tubular wall extending along a longitudinal axisbetween opposite first and second end surfaces, the drive being spacedapart from the screw by the second end surface, the drive and the screwbeing coaxial with the longitudinal axis.
 6. The surgical instrumentrecited in claim 5, wherein the second end surface extends perpendicularto the longitudinal axis.
 7. The surgical instrument recited in claim 1,wherein the first member includes a tubular wall extending along alongitudinal axis between opposite first and second end surfaces, thedrive extending outwardly from the second end surface such that thedrive permanently fixed to the second end surface, the second endsurface extending perpendicular to the longitudinal axis.
 8. Thesurgical instrument recited in claim 1, wherein the first memberincludes a tubular wall extending along a longitudinal axis betweenopposite first and second ends, the second end including a window, thescrew being visible through the window to confirm engagement of theouter thread surface with the second mating surface.
 9. The surgicalinstrument recited in claim 8, wherein the first end includes a collarbody, the collar body comprising bifurcated arms, the arms defining acavity therebetween, the surgical instrument comprising a thumbwheelpositioned in the cavity, the thumbwheel being configured to rotate thesecond member relative to the first member about the longitudinal axis.10. The surgical instrument recited in claim 1, wherein the first memberincludes a tubular wall extending along a longitudinal axis betweenopposite first and second ends, the first end including a collar body,the collar body comprising bifurcated arms, the arms defining a cavitytherebetween, the surgical instrument comprising a thumbwheel positionedin the cavity, the thumbwheel being configured to rotate the secondmember relative to the first member about the longitudinal axis.
 11. Thesurgical instrument recited in claim 1, wherein the first memberincludes a tubular wall extending along a longitudinal axis betweenopposite first and second ends, the first end including a collar body,the collar body comprising first and second arms, the first arm beingconnected to the second arm by a ring, the ring comprising an opening,the opening being coaxial with the longitudinal axis, the surgicalinstrument comprising a shaft extending through the opening such thatthe shaft is fixed relative to the first member.
 12. The surgicalinstrument recited in claim 11, wherein a distal end of the shaftextends through the opening and an opposite proximal end of the shaftcomprises a polygonal cross-sectional configuration, the proximal endbeing configured for engagement with a drill, the proximal end having amaximum diameter, the maximum diameter of the proximal end being lessthan a maximum diameter of the distal end.
 13. The surgical instrumentrecited in claim 1, wherein the drive comprises a distal tip of thefirst member and the first mating surface includes a drive socket of abone fastener shaft.
 14. The surgical instrument recited in claim 1,further comprising a thumbwheel coupled to the first end, the thumbwheelbeing configured to rotate the second member relative to the firstmember about the longitudinal axis.
 15. The surgical instrument recitedin claim 14, wherein the thumbwheel is coupled to the first end by a pinand the first member is monolithic, the instrument consisting of themembers, the pins and the thumbwheel.
 16. A surgical system comprising:a bone fastener including a screw and a receiver, the screw beingrotatable relative to the receiver, the screw comprising a first matingsurface, the receiver comprising a second mating surface; and a surgicalinstrument comprising a first member including a drive, the drive beingengageable with the first mating surface, the surgical instrumentcomprising a second member, the second member including a screwengageable with the second mating surface, the screw being fixed to adistal end of the second member by a pin, the screw having an outerthread surface connectable with the second mating surface, the firstmember defining an inner cavity, the second member being rotatablydisposed within the inner cavity.
 17. The surgical system recited inclaim 16, wherein the screw has a maximum diameter, the maximum diameterof the screw being greater than a maximum diameter of the drive.
 18. Thesurgical system recited in claim 16, wherein the first member includes atubular wall extending along a longitudinal axis between opposite firstand second end surfaces, the drive extending outwardly from the secondend surface such that the drive and the screw are coaxial with thelongitudinal axis, the screw being spaced apart from the drive by thesecond end surface, the second end surface extending perpendicular tothe longitudinal axis.
 19. A surgical system comprising: a bone fastenerincluding a screw and a receiver, the screw being rotatable relative tothe receiver, the screw comprising a socket, the receiver comprising afemale thread form; and a surgical instrument comprising a first memberincluding a drive, the drive being configured for disposal in thesocket, the surgical instrument comprising a second member, the secondmember including a screw, the screw being fixed to a distal end of thesecond member by a pin, the screw comprising a male thread formengageable with the female thread form, the first member defining aninner cavity, the second member being rotatably disposed within theinner cavity.
 20. The surgical system recited in claim 19, wherein thescrew has a maximum diameter, the maximum diameter of the screw beinggreater than a maximum diameter of the drive.